The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT03871673
• Date of registration: 09/03/2019
• Prospective Registration: No
• Primary sponsor: Hospital de Clinicas de Porto Alegre
• Public title: The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases
• Scientific title: A Novel Approach to Treatment of Hepatic Glycogen Storage Diseases: a Study Based on the Use of Uncooked Sweet Manioc Starch
• Date of first enrolment: April 29, 2017
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03871673
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Ida D Schwartz, Dr
• Affiliation: Hospital de Clínicas de Porto Alegre

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with a confirmed molecular diagnosis of glycogen storage disease type Ia who
are already on uncooked cornstarch therapy

Exclusion Criteria:

-



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glycogen Storage Disease Type I

Intervention(s)

Dietary Supplement: Sweet manioc starch

Dietary Supplement: Cornstarch

Primary Outcome(s)

Duration of normoglycemia [Time Frame: up to 10 hours]

Secondary Outcome(s)

Lactate levels [Time Frame: up to 10 hours]

Glucose levels [Time Frame: up to 10 hours]

Insulin levels [Time Frame: up to 10 hours]

Secondary ID(s)

160056

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Fundação Médica do Rio Grande do Sul